Study Details

Open

ERAS-601-01 (FLAGSHP-1)

This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-601 as a monotherapy and in combination with cetuximab. The study commenced with dose escalation of ERAS-601 monotherapy (Parts A and B). After review of the initial clinical and pharmacokinetic (PK) data from Parts A and B, additional monotherapy schedules have been added (Parts C1).

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will meet with a member of the study team. The study also involves blood draws, bone scans, CT/MRI (imaging assessments), and willingness to take the study medication regularly.

In-person visits:
About 10 - 12

Total length of participation:
Up to 2 years

Looking for Specific Volunteers

Able to participate:

You have histologically or cytologically confirmed advanced or metastatic solid tumor(s)
You have recovered from all toxicities associated with prior treatment to acceptable baseline status
You have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 with an anticipated life expectancy of greater than 12 weeks.
You are willing to comply with all protocol-required visits, assessments, and procedures

Not eligible if:

You have previous treatment with a SHP2 inhibitor
You have documented PTPN11 mutations
You are currently receiving another study therapy or participated in a study of an investigational agent and received study therapy within 4 weeks of start
You require treatment with other drugs associated with central anticholinergic activity, including typical and atypical antipsychotics
You have uncontrolled diarrhea or inflammatory bowel disease; History of calcium and phosphate homeostasis disorder or systemic mineral imbalance with ectopic soft tissue calcification.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Sid Sheth
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck)

IRB Number

22-3149

ClinicalTrials.gov

NCT04670679